ES2246265T3 - DEVICE FOR THE CONTROLLED INHALATION OF THERAPEUTIC AEROSOLS. - Google Patents
DEVICE FOR THE CONTROLLED INHALATION OF THERAPEUTIC AEROSOLS.Info
- Publication number
- ES2246265T3 ES2246265T3 ES01106363T ES01106363T ES2246265T3 ES 2246265 T3 ES2246265 T3 ES 2246265T3 ES 01106363 T ES01106363 T ES 01106363T ES 01106363 T ES01106363 T ES 01106363T ES 2246265 T3 ES2246265 T3 ES 2246265T3
- Authority
- ES
- Spain
- Prior art keywords
- inhalation
- parameters
- patient
- inhalation device
- individual
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/01—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes specially adapted for anaesthetising
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0057—Pumps therefor
- A61M16/0072—Tidal volume piston pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/22—Carbon dioxide-absorbing devices ; Other means for removing carbon dioxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
- A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
- A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
- A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
- A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory circuit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
- A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
- A61M2016/0042—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the expiratory circuit
Abstract
Description
Dispositivo para la inhalación controlada de aerosoles terapéuticos.Device for controlled inhalation of therapeutic sprays
La invención se refiere a un dispositivo para la inhalación controlada de aerosoles terapéuticos y en especial para la dosimetría individual de aerosoles inhalables.The invention relates to a device for the controlled inhalation of therapeutic aerosols and especially for the individual dosimetry of inhalable aerosols.
En la inhalación de medicamentos en forma de aerosoles varios factores determinan el depósito del principio activo en el pulmón. El depósito del principio activo en el pulmón depende de las propiedades de las partículas del principio activo a inhalar, como por ejemplo tamaño de partícula, carga eléctrica e higroscopicidad, de la velocidad de inhalación (es decir del flujo respiratorio) del paciente y de la profundidad de inhalación (es decir del volumen respiratorio) de una inspiración del paciente a tratar.In the inhalation of medications in the form of various factors aerosols determine the deposit of the principle active in the lung. The deposit of the active substance in the lung depends on the properties of the particles of the active substance at inhale, such as particle size, electrical charge and hygroscopicity, of the inhalation rate (ie flow respiratory) of the patient and the depth of inhalation (it is say of the respiratory volume) of an inspiration of the patient to try.
En distintos medicamentos que deben administrarse por inhalación en forma de aerosol la cantidad del principio activo inhalado debe dosificarse exactamente, pues una sobredosificación eventual para los pacientes sería crítica. En los métodos habituales de inhalación ciertamente se ajusta el tamaño de partícula al medicamento a administrar, pero el paciente posee respecto a su patrón respiratorio una gran libertad, de modo que la dosificación individual puede oscilar muy fuertemente. En un proceso de inhalación débil (inhalación plana, rápida) se administra demasiado poco medicamento, mientras que una inhalación demasiado fuerte (inhalación profunda, lenta) tiene por consecuencia una sobredosificación.In different medications to be administered by inhalation in aerosol form the amount of the active substance inhaled must be dosed exactly, as an overdose Eventually for patients it would be critical. In the usual methods of inhalation certainly adjusts the particle size to medication to be administered, but the patient has respect to his respiratory pattern a great freedom, so that the dosage individual can swing very strongly. In a process of weak inhalation (flat, fast inhalation) is given too much little medication while an inhalation too strong (deep, slow inhalation) results in a overdosing
El documento WO 92/07599 se refiere al proceso de calibración durante la fabricación de un inhalador de tipo MDI.WO 92/07599 refers to the process of Calibration during the manufacture of an MDI type inhaler.
El documento
EP-B-0 587 380 describe un
dispositivo de suministro de medicamento que reconoce una inhalación
y administra el medicamento respectivamente solo durante una
inhalación, pero el paciente tiene la libertad de respirar
discrecionalmente. Esta libertad varía además de paciente a
paciente, lo que conduce a una considerable variabilidad en la
dosificación. El documento EP-A-0
965 355 describe un inhalador controlado con un volumen de aerosol
predeterminado y una limitación del flujo de inhalación. En este
inhalador se ajusta el flujo respiratorio y el volumen respiratorio
en límites precisos, pero este inhalador no debe ajustarse como
producto másico a los presupuestos concretos respecto a la función
pulmonar de un individuo concreto. Para el volumen respiratorio y el
flujo respiratorio se ajustan parámetros que son aceptables para una
gran parte de los pacientes, pero no posibilitan ninguna aportación
óptima de principio activo para los distintos pacien-
tes.EP-B-0 587 380 describes a medication delivery device that recognizes an inhalation and administers the medication respectively only during an inhalation, but the patient has the freedom to breathe discretionary. This freedom also varies from patient to patient, which leads to considerable variability in dosage. EP-A-0 965 355 describes a controlled inhaler with a predetermined aerosol volume and a limitation of inhalation flow. In this inhaler the respiratory flow and the respiratory volume are adjusted to precise limits, but this inhaler should not be adjusted as a mass product to the specific budgets regarding the lung function of a particular individual. For the volume of the respiratory and the respiratory flow, parameters that are acceptable for a large part of the patients are adjusted, but do not allow any optimal contribution of active ingredient to the different patients.
tes.
Por consiguiente en la práctica se presentan los siguientes problemas:Therefore, in practice, the following problems:
- 1.one.
- Muchos pacientes obstructivos graves ya no pueden aplicar un flujo respiratorio determinado necesario, que deberían generar sin embargo para una administración óptima del aerosol;Many serious obstructive patients already they cannot apply a necessary determined respiratory flow, which they should generate however for optimal administration of the aerosol;
- 2.2.
- Muchos de estos pacientes tan solo pueden inhalar volúmenes muy limitados, lo que ante todo es el caso en pacientes con enfisema pulmonar o pacientes con volúmenes pulmonares muy pequeños;Many of these patients just they can inhale very limited volumes, which is first of all the case in patients with pulmonary emphysema or patients with volumes very small lungs;
- 3.3.
- Cada paciente inhala con distinta velocidad y volumen, de modo que se producen fuertes oscilaciones de la dosis de medicamento que llega al pulmón.Every patient inhales with different speed and volume, so that produce strong oscillations of the dose of medication that arrives to the lung
La invención se plantea el objetivo de
proporcionar un dispositivo mejorado para la inhalación de aerosoles
terapéuticos. Este objetivo se soluciona con las características de
la reivindicación independien-
te.The invention aims to provide an improved device for the inhalation of therapeutic aerosols. This objective is solved with the characteristics of the independent claim.
tea.
La invención parte del concepto básico de prever en un dispositivo de inhalación un mecanismo que proporcione parámetros de pacientes individuales y/o parámetros de aerosol para la inhalación así como de prever un mecanismo que efectúe la dosificación individual del aerosol o de los aerosoles en función de los parámetros de pacientes individuales y/o de aerosol proporcionados. De este modo puede adaptarse conforme a la invención el dispositivo de inhalación individualmente a las posibilidades del paciente.The invention is based on the basic concept of providing in an inhalation device a mechanism that provides individual patient parameters and / or aerosol parameters for inhalation as well as to provide a mechanism that effects the individual dosage of aerosol or aerosols depending on the parameters of individual patients and / or aerosol provided. In this way it can be adapted according to the invention the inhalation device individually to the possibilities of patient.
Según una primera forma de realización se proporcionan los parámetros individuales a un medio de memoria como los que pueden adquirirse bajo las denominaciones de SmartCard, FlashCard o SmartLabel. Los parámetros individuales se archivan en el medio de memoria por ejemplo tras una medición de la función pulmonar actual del paciente (por ejemplo por el médico de cabecera). Este, según una primera forma de realización, se inserta entonces por el paciente (en casa) en el dispositivo de inhalación, después de lo cual se leen los datos individuales. De modo alternativo el medio de memoria se introduce en un dispositivo separado desde el que a partir de los parámetros individuales se trasmiten al dispositivo de inhalación. Según otra forma de realización alternativa está previsto un módem, de modo que por parte del medico de tratamiento o la institución asistencial se suministran al dispositivo de inhalación a través de una línea de datos (por ejemplo línea telefónica) los parámetros individuales.According to a first embodiment, they provide the individual parameters to a memory medium like those that can be purchased under the SmartCard denominations, FlashCard or SmartLabel. Individual parameters are archived in the memory medium for example after a function measurement current pulmonary of the patient (for example by the doctor of Headboard). This, according to a first embodiment, is inserted then by the patient (at home) in the inhalation device, after which the individual data is read. So alternatively the memory medium is inserted into a device separated from which from the individual parameters transmitted to the inhalation device. According to another form of alternative embodiment a modem is provided, so that by part of the treatment doctor or the healthcare institution supplied to the inhalation device through a line of data (eg telephone line) parameters individual.
Según otra forma de realización está previsto un mecanismo para la introducción manual de los parámetros individuales, por ejemplo mediante teclas correspondientes. Como alternativa, en el dispositivo de inhalación conforme a la invención se ajustan los parámetros individuales por medio de reguladores manuales o conmutadores manuales.According to another embodiment, a mechanism for manually entering parameters individual, for example by corresponding keys. How alternatively, in the inhalation device according to the invention the individual parameters are adjusted by means of regulators manuals or manual switches.
Los parámetros individuales del paciente y/o los parámetros del aerosol actúan por consiguiente manual o automáticamente (por ejemplo a través de un correspondiente control de válvulas) sobre la dosificación individual del aerosol o de los aerosoles. Como la dependencia de la deposición de un aerosol en determinadas zonas del pulmón en función del tamaño de partícula del principio activo, del volumen respiratorio y del flujo respiratorio es conocida, puede por consiguiente predeterminarse substancialmente conforme a la invención la deposición de aerosol en el pulmón. El paciente experimenta la maniobra respiratoria ajustada como agradable puesto que está adaptada a sus posibilidades.The individual parameters of the patient and / or the aerosol parameters act accordingly manual or automatically (for example through a corresponding control of valves) on the individual dosage of the spray or aerosol sprays. As the dependence of the deposition of an aerosol in certain areas of the lung depending on the particle size of the active substance, respiratory volume and respiratory flow is known, can therefore be predetermined substantially according to the invention aerosol deposition in the lung. He patient experiences the adjusted breathing maneuver as nice since it is adapted to your possibilities.
Preferiblemente, la maniobra respiratoria respectivamente realizada por el paciente sobre el medio de memoria del dispositivo de inhalación se archiva, de modo que tras un cierto periodo de tratamiento puede llevarse a cabo un control de la aplicación.Preferably, the respiratory maneuver respectively performed by the patient on the memory medium of the inhalation device is archived, so that after a certain treatment period a control of the application.
Además, preferiblemente el medio de memoria puede programarse de nuevo para proporcionar en caso de variaciones en la función respiratoria del paciente parámetros correspondientemente adaptados para la correcta maniobra respiratoria.In addition, preferably the memory medium can programmed again to provide in case of variations in the Respiratory function of the patient parameters correspondingly adapted for the correct respiratory maneuver.
Preferiblemente, con el dispositivo de inhalación conforme a la invención se impide una sobredosificación, por ejemplo predeterminando un tiempo de acción o un bloqueo de acción, por ejemplo en el medio de memoria. Esto impide una activación del dispositivo de inhalación por el paciente en tanto no haya transcurrido el tiempo necesario entre dos inhalaciones sucesivas. Preferiblemente, el medio de memoria sirve también para la protocolización de errores. Por ejemplo se protocoliza si se presenta una elevada desviación de la presión de nebulización de un valor nominal o si la presión de nebulización necesaria no ha podido establecerse. Además se protocoliza en el medio de memoria preferiblemente una eventual desconexión de seguridad en caso de una presión demasiado elevada en la boquilla (presión de insuflación). Además, es preferida la protocolización de una desviación demasiado elevada del flujo (bien del flujo de nebulización del aerosol o del flujo auxiliar del aire adicional suministrado al aire de nebulización o de la suma de ambos flujos) o de un aviso de error cuando no ha podido establecerse uno de los mencionados flujos para la inhalación. Preferiblemente se protocoliza también una interrupción de la inhalación del paciente.Preferably, with the inhalation device an overdose is prevented according to the invention, for example predetermining an action time or an action lock, by example in the middle of memory. This prevents an activation of the inhalation device by the patient as long as there is no after the necessary time between two successive inhalations. Preferably, the memory medium also serves the protocol of errors. For example it is protocolized if it has a high deviation from the fogging pressure of a nominal value or if the necessary fogging pressure could not settle. In addition it is protocolized in the memory medium preferably a possible safety shutdown in case of a pressure too high at the nozzle (insufflation pressure). In addition, the protocolization of a deviation too much is preferred high flow rate (either from the spray mist flow or from the auxiliary flow of the additional air supplied to the air of nebulization or the sum of both flows) or an error message when one of the aforementioned flows has not been established for inhalation Preferably, a interruption of patient inhalation.
Preferiblemente también se archiva en el medio de memoria el nombre del medicamento que se va a inhalar.Preferably it is also archived in the middle of memory the name of the medication to be inhaled.
Además, según una forma de realización preferida se proporciona una autorización de acceso para servicio al cliente. A este respecto, mediante una codificación especial del medio de memoria en el dispositivo de inhalación se activa un software que está a disposición con fines de asistencia.In addition, according to a preferred embodiment an access authorization is provided for customer service. In this regard, through a special coding of the means of memory in the inhalation device software is activated that It is available for assistance purposes.
El dispositivo de inhalación conforme a la invención presenta las siguientes ventajas:The inhalation device according to the The invention has the following advantages:
- 1.one.
- Para cada paciente se ajusta o predetermina una maniobra de inhalación individual agradable y óptima;For each patient adjusts or predetermines an inhalation maneuver nice and optimal individual;
- 2.2.
- Mediante la predeterminación de parámetros individuales pueden administrarse al pulmón distintas substancias en distintos intervalos deseados;By default of individual parameters can be administered to the lung differently substances at different desired intervals;
- 3.3.
- Se incrementa la reproducibilidad del suministro de principio activoBe increases the reproducibility of the principle supply active
- 4.Four.
- Se administra al paciente en el pulmón la dosis óptima del principio activo en el intervalo deseado;Be administer the optimal dose of the principle to the patient in the lung active in the desired range;
- 5.5.
- Mediante la programación de distintas maniobras respiratorias pueden inhalarse distintos medicamentos con un aparato respectivamente de modo óptimo y adaptado al paciente;By programming different respiratory maneuvers can inhale different medications with an apparatus respectively optimally and adapted to the patient;
- 6.6.
- El dispositivo de inhalación conforme a la invención puede ajustarse inmediatamente a nuevas substancias, nuevas maniobras respiratorias y distintos flujos respiratorios (update, actualización);He inhalation device according to the invention can be adjusted immediately to new substances, new respiratory maneuvers and different respiratory flows (update, update);
- 7.7.
- En un medio de memoria, como por ejemplo una SmartCard, pueden registrarse las maniobras respiratorias en el transcurso de una terapia y evaluarse a continuación;In a Memory media, such as a SmartCard, can be registered respiratory maneuvers during a therapy and be evaluated below;
- 8.8.
- Si se produce una variación de la función pulmonar del paciente puede ajustarse sin más el dispositivo de inhalación a la condición marco variada;Whether produces a variation of the patient's lung function can adjust the inhalation device to the frame condition varied;
- 9.9.
- No es imprescindible el uso de un propulsor.It is not The use of a propeller is essential.
Conforme a la invención pueden utilizarse todos los medicamentos que desplieguen su efecto bien tópicamente en el tracto respiratorio o también sistémicamente. Los medicamentos adecuados comprenden analgésicos, agentes antiangina, antialérgicos, histamínicos y antiinflamatorios, expectorantes, antitusivos, broncodilatadores, diuréticos, anticolinérgicos, corticoides, xantinas, antitumorales así como proteínas o péptidos con actividad terapéutica como insulina o interferón.According to the invention all can be used medicines that display their effect well topically in the respiratory tract or also systemically. The drugs Suitable include analgesics, antianginal agents, antiallergics, histamines and anti-inflammatory, expectorant, cough suppressant, bronchodilators, diuretics, anticholinergics, corticosteroids, xanthines, anti-tumor as well as proteins or peptides with activity therapeutic as insulin or interferon.
Es preferida la administración de medicamentos para el tratamiento de enfermedades respiratorias como asma, así como agentes para la profilaxis y el tratamiento de las mucosas del tracto traqueo-bronquial. Es especialmente preferida la administración de ésteres del retinol así como del ácido retinoico ("vitamina A") como se describe en el documento EP-A-0 352 412. Los medicamentos pueden estar presentes en forma libre o como sal farmacéuticamente aceptable o como éster. Otra posibilidad consiste en encerrar el medicamento en liposomas.Medication administration is preferred for the treatment of respiratory diseases such as asthma as well as agents for the prophylaxis and treatment of mucous membranes tracheo-bronchial tract. It is especially preferred administration of retinol esters as well as acid retinoic acid ("vitamin A") as described in the document EP-A-0 352 412. Medications they can be present in free form or as a pharmaceutically salt acceptable or as ester. Another possibility is to enclose the medicine in liposomes.
Los medicamentos pueden confeccionarse con excipientes farmacéuticamente aceptables habituales.Medications can be made with usual pharmaceutically acceptable excipients.
Claims (9)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10013093A DE10013093B4 (en) | 2000-03-17 | 2000-03-17 | Device for the controlled inhalation of therapeutic aerosols |
DE10013093 | 2000-03-17 |
Publications (1)
Publication Number | Publication Date |
---|---|
ES2246265T3 true ES2246265T3 (en) | 2006-02-16 |
Family
ID=7635149
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES01106363T Expired - Lifetime ES2246265T3 (en) | 2000-03-17 | 2001-03-16 | DEVICE FOR THE CONTROLLED INHALATION OF THERAPEUTIC AEROSOLS. |
Country Status (7)
Country | Link |
---|---|
US (1) | US7766012B2 (en) |
EP (1) | EP1136093B1 (en) |
AT (1) | ATE302629T1 (en) |
CY (1) | CY1107981T1 (en) |
DE (2) | DE10013093B4 (en) |
DK (1) | DK1136093T3 (en) |
ES (1) | ES2246265T3 (en) |
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2000
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- 2001-03-16 US US09/810,988 patent/US7766012B2/en not_active Expired - Fee Related
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CY1107981T1 (en) | 2013-09-04 |
EP1136093A2 (en) | 2001-09-26 |
ATE302629T1 (en) | 2005-09-15 |
EP1136093B1 (en) | 2005-08-24 |
DE10013093A1 (en) | 2001-10-04 |
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